Trial Outcomes & Findings for The CHICA Developmental Screening Study (NCT NCT01351077)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

360 participants

Primary outcome timeframe

one year

Results posted on

2017-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	CHICA DevScreen Module This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control This arm will get CHICA without the developmental screening module
Overall Study STARTED	180	180
Overall Study COMPLETED	180	180
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The CHICA Developmental Screening Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHICA DevScreen Module n=180 Participants This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control n=180 Participants This arm will get CHICA without the developmental screening module	Total n=360 Participants Total of all reporting groups
Age, Continuous	19.8 months STANDARD_DEVIATION 5.1 • n=5 Participants	23.7 months STANDARD_DEVIATION 6.5 • n=7 Participants	21.8 months STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	91 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	89 Participants n=7 Participants	172 Participants n=5 Participants
Race/Ethnicity, Customized Black	51 Participants n=5 Participants	164 Participants n=7 Participants	215 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	117 Participants n=5 Participants	11 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized White/Asian	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Insurance Advantage/Commercial	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Insurance Self-pay	12 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants
Insurance Medicaid	160 Participants n=5 Participants	171 Participants n=7 Participants	331 Participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	CHICA DevScreen Module n=180 Participants This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control n=180 Participants This arm will get CHICA without the developmental screening module
Number of Children Screened for Developmental Delay	153 Participants	44 Participants

SECONDARY outcome

Timeframe: one year

Population: The denominator was only children diagnosed with developmental delay

Outcome measures

Outcome measures
Measure	CHICA DevScreen Module n=19 Participants This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control n=12 Participants This arm will get CHICA without the developmental screening module
Age of Children Diagnosed With Developmental Delay	19.8 months Standard Deviation 5.1	23.8 months Standard Deviation 6.5

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

Population: The denominator was number of children for whom a standard developmental screening tool was administered

Outcome measures

Outcome measures
Measure	CHICA DevScreen Module n=153 Participants This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control n=44 Participants This arm will get CHICA without the developmental screening module
Number of Children With a Positive Screen	30 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

Population: The denominator was the number of children with a positive screen

Outcome measures

Outcome measures
Measure	CHICA DevScreen Module n=30 Participants This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control n=8 Participants This arm will get CHICA without the developmental screening module
Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result	22 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	CHICA DevScreen Module n=22 Participants This arm will get the CHICA Developmental Screening Module CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening	CHICA DevScreen Control n=4 Participants This arm will get CHICA without the developmental screening module
Number of Patients Whose Referred Evaluations and Services Were Completed	12 Participants	1 Participants

Adverse Events

CHICA DevScreen Module

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CHICA DevScreen Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron E. Carroll, MD, MS

Indiana University School of Medicine

Phone: 3172789616

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place